Author: Dan Sterling | Date: February 3, 2015
ISO 14971 is the application of a risk management process for medical devices. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis. This standard helps guide the process for medical device manufacturers to ensure that the product is safe.
by Nick Oshman
Director of Quality Assurance, Sterling Medical Devices
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